Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Completed · Not applicable
Conditions studied: Meningitis, Cryptococcal, HIV Infections
In brief
To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.
Key facts
- Study ID
- NCT00002076
- Run by
- Pfizer
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Allowed:
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
- Concurrent Treatment:
- Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
- No prior systemic antifungal therapy for cryptococcosis.
- Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.
- Prior Medication:
- Allowed:
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
You may not qualify if…
- Co-existing Condition:
- Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease defined by specified lab values.
- Patients who are unable to take oral medication.
- Unlikely to survive more than 2 weeks.
- Renal impairment.
- Concurrent Medication:
- Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
- Concurrent Treatment:
- Excluded:
- Lymphocyte replacement.
- Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy to or intolerance of imidazoles or azoles.
Where it is running
- Summitt Med Ctr / San Francisco Gen Hosp — Oakland, California, United States
- Cornell Univ Med Ctr — New York, New York, United States
- Buckley Braffman Stern Med Associates — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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